On February 18 , 2022 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported that the U.S. Food and Drug Administration ("FDA") has provided the Company with Refusal to File ("RTF") letters regarding the new drug application ("NDA") for dovitinib, and its accompanying pre-market approval ("PMA") application for the DRP-Dovitinib companion diagnostic, for the third-line treatment of metastatic renal cell carcinoma ("mRCC") (Press release, Allarity Therapeutics, FEB 18, 2022, View Source [SID1234608338]).
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Upon preliminary review, the FDA determined that the NDA, submitted on December 22, 2021, and the PMA application, submitted on April 2, 2021, were not sufficiently complete to permit substantive reviews. In the letter regarding the NDA, the FDA’s cited reasons for the RTF decision primarily include, but are not limited to, that submitted clinical trial data do not enable a conclusion of efficacy based on non-inferiority data set. Given that the PMA and NDA were filed as related applications, the RTFs also apply to the DRP-Dovitinib companion diagnostic.
Allarity intends to seek immediate guidance from the FDA, which potentially includes requesting a Type A meeting with the agency to clarify and respond to the issues identified in the RTF letters and seek additional guidance concerning information, data, and specific deliverables that the agency would require for a resubmitted NDA and PMA to be deemed complete. The Company anticipates that a new prospective clinical trial will be required to overcome the FDA’s outstanding objections.
"We remain highly confident in the clinical profile of dovitinib, together with the DRP-Dovitinib companion diagnostic, and remain committed to advancing this product candidate as a potential new treatment option for individuals with mRCC," said Allarity’s CEO Steve Carchedi. "We are fully determined to work with the FDA staff as quickly as possible to address the open issues and clarify the path to successfully re-filing our applications."